Regulatory Compliance Pharmacist

Job Opportunity At Emory Healthcare

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Pharmacist Role

Job Summary: We are seeking an experienced pharmacist to oversee our regulatory and compliance program as it relates to federal and state requirements (GA BOP, DEA, DSCSA, FDA), diversion prevention, controlled substance accountability, proper medication handling, accreditation survey readiness, adherence to USP standards, and patient safety initiatives.

Primary duties and responsibilities:

1. Oversees and optimizes data analytics related to the identification and prevention of controlled substance mismanagement and drug diversion.
2. Coordinates timely investigations of suspected drug diversion in collaboration with the appropriate site leaders and the drug diversion response team.
3. Assists with education and coaching following a confirmed case of diversion and reports/documentation is complete timely adhering to regulatory requirements.
4. Provides education, coaching and training as necessary following discrepancies and/or deviation from standard operating procedures.
5. Performs audits related to regulatory requirements including, but not limited to, manual and electronic USP and compliance related documentation.
6. Assists with investigating pharmacy medication safety events and participates in relevant multi-disciplinary meetings.
7. Evaluates and facilitates workflow modifications to prevent diversion and/or meet regulatory and accreditation requirements.
8. Serves as the primary backup to the controlled substance coordinator as needed and as applicable.
9. Participates in proactive review and audits of high-risk diversion practices and required clinical and operational documentation.
10. Reviews and presents key performance indicator data related to regulatory, compliance, and accreditation to local and system leadership.
11. Works collaboratively with both internal and system pharmacy, operational, and clinical leadership.
12. Maintains open and effective communication with all stakeholders, providing updates and insights into findings.
13. Attends and participates in system and key stakeholder meetings related to drug diversion, compliance, safety, security, and accreditation.
14. Provides education sessions for pharmacy, nursing, and/or provider teams as needed.
15. Identifies opportunities to improve patient safety, medication management, and accreditation best practices.
16. Promotes standardization and best practice implementation where appropriate.
17. Prepares financial/operational/clinical/quality analysis materials for process improvement.
18. Serves as the primary liaison between pharmacy operations, compliance, and leadership to ensure consistent adherence to accreditation and regulatory requirements.
19. Completes and maintains documentation as it relates to investigational activities, compliance tasks, and third-party audits, as applicable.
20. Coordinates and/or participates in safety event response team meetings and ensures timely follow-up.
21. Tracks and assists with REMS program compliance and audits.
22. Audits receiving, ordering, and processing of controlled substances and other high-risk medications.
23. Ensures adherence to federal, state, and local regulations including licensing, certifications, training, and collaborative practice agreements as applicable.
24. Assists leadership in inspection or survey preparation and readiness related to BOP, GDNA, DEA, TJC, URAC, ACHC, and any other regulatory agencies.
25. Supports adherence to USP standards including <659>, <795>, <797>, and <800> as applicable.
26. Leads outcomes reporting and benchmarking related to accreditation as applicable.
27. Supports controlled substance, regulatory, compliance, and accreditation policy, procedure, and best practice development and implementation.

Travel And Work Type

Travel: Less than 10% of the time may be required. Work Type: In person

Minimum Qualifications

Education: Graduate of an accredited school of Pharmacy. Experience: 3 years of applicable experience Licensure: Current Georgia Pharmacist License

Preferred Qualifications

Education: ASHP accredited residency Experience: Previous diversion oversight, accreditation, and/or safety experience

Physical Requirements

Physical Requirements (Medium Max 25lbs): up to 25 lbs., 0-33% of the work day (occasionally) Lifting 25 lbs. max; Carrying of objects up to 25 lbs.; Occasional to frequent standing & walking, Occasional sitting, Close eye work (computers, typing, reading, writing), Physical demands may vary depending on assigned work area and work tasks. Environmental factors affecting environmental conditions may vary depending on the assigned work area and tasks. Environmental exposures include but are not limited to: Blood-borne pathogen exposure, Bio-hazardous waste chemicals/gases/fumes/vapors, Communicable diseases, Electrical shock, Floor Surfaces, Hot/Cold Temperatures, Indoor/Outdoor conditions, Latex, Lighting, Patient care/handling injuries, Radiation, Shift work, Travel may be required. Use of personal protective equipment, including respirators, and environmental conditions may vary depending on assigned work area and work tasks.